Regenerative Patch Technologies (RPT) Announces Treatment of First Two Patients in Phase IIb Clinical Trial Assessing the Safety and Efficacy of its Allogeneic Bioengineered RPE Cell Implant for t...

The Phase IIb clinical trial advances clinical development of RPT's lead product to confirm the safety, efficacy, and durability signals seen in its Phase I/IIa clinical trial.

MENLO PARK, Calif., Dec. 9, 2025 /PRNewswire/ -- Regenerative Patch Technologies LLC (RPT) announced treatment of the first two participants in a Phase IIb clinical trial entitled, "A Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial to Assess the Safety and Efficacy of Subretinal Implantation of the CPCB-RPE1 implant in Patients with Advanced, Dry Age-Related Macular Degeneration (Geographic Atrophy) – PATCH AMD." The trial is designed to generate safety and efficacy data from additional subjects and be additive to the dataset from the already completed Phase I/IIa study. In the Phase I/IIa trial, patients were followed for a mean of 36.9 months (range 12-54 months). As of final follow-up, 27% of treated eyes showed a >5 letter gain in visual acuity compared to 7% of the untreated fellow eyes. A larger proportion of nonimplanted eyes demonstrated >5 letter vision loss (80% vs 47%) compared to that of the treated eye.

"Initiation of the Phase IIb clinical trial marks an important milestone for RPT," said Jane Lebkowski PhD, President of Regenerative Patch Technologies, LLC. "Based on our Phase I/IIa clinical trial results, the Phase IIb trial provides an opportunity to collect clinical data in patients with less severe disease to confirm the implant's ability to improve vision."

"The Phase IIb clinical trial incorporates use of a cryopreserved formulation of the implant," stated Linc Johnson PhD and Chief Scientific Officer of RPT. "This long-term storage format facilitates shipment to clinical treatment sites where it is thawed immediately before implantation."

"This is an important clinical trial in the development of treatments for geographic atrophy," stated Suber Huang, MD, MBA, FASRS and Chief Executive Officer of the Retina Center of Ohio. "To date, the only treatments available to patients with geographic atrophy involve frequent injections in the eye which simply slow growth of the lesion. The development of a therapy that safely improves vision would be a major breakthrough for the field."

The Phase IIb trial is being conducted at multiple sites in California, Illinois and Texas.

Further details of the trial and the clinical trial sites can be found at
https://clinicaltrials.gov/study/NCT06557460.

RPT is especially grateful to those organizations that have provided funding for this clinical trial.  These include the California Institute for Regenerative Medicine (CIRM), the Marcus Foundation, and the University of Southern California. Their support has been critical to advancing this program.

About Regenerative Patch Technologies and the CPCB-RPE1 Implant

Regenerative Patch Technologies LLC is a clinical-stage company developing a stem cell-based implant technology for the treatment of retinal diseases. The CPCB-RPE1 implant, RPT's lead product, is a bio-engineered implant consisting of stem cell-derived, retinal pigmented epithelial (RPE) cells on an ultrathin synthetic parylene membrane. The implant is designed to replace the retinal pigmented epithelium and Bruch's membrane in the eye that degenerate in dry age-related macular degeneration. The deterioration of these structures diminishes critical spatial, metabolic, and growth-factor support essential for the survival and function of the retinal photoreceptors, leading to vision loss and blindness. The CPCB-RPE1 implant serves to replace the damaged RPE cell layer and Bruch's membrane in the region of geographic atrophy. The technology to produce the CPCB-RPE1 implant is exclusively licensed to RPT from the University of Southern California Stevens Center for Innovation, the California Institute of Technology, and University of California, Santa Barbara. 

About Dry Age-Related Macular Degeneration

Dry age-related macular degeneration is the most common form of age-related macular degeneration, occurring in 90% of people who have AMD. The advanced dry form of age-related macular degeneration, geographic atrophy, is the leading cause of blindness in adults, affecting 10-20% of people in the United States over the age of 65.

For inquiries contact:

Regenerative Patch Technologies LLC
inquiries@regenerativepatch.com
1-650-394-5835

For clinical trial inquiries, contact
clinicaltrials@regenerativepatch.com

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